The Food and Drug Administration has approved a new cholesterol鈥憀owering pill that could help millions of Americans.
Merck鈥檚 Lipfendra, the brand name for the drug enlicitide, belongs to a class of medications known as PCSK9 inhibitors. Until now, these drugs were only available as injections. Lipfendra is a tablet taken once a day and is the first oral PCSK9 inhibitor to win FDA approval.
鈥淭reating cholesterol more aggressively or more fully is our best chance to lower the risk for heart disease for millions and millions of Americans,鈥� said Dr. Allen Taylor, chairman for cardiology at MedStar Heart & Vascular Institute. 鈥淲hatever your cholesterol number is, it probably should be lower.鈥�
Taylor, , called the pill a breakthrough in expanding the medication鈥檚 reach, letting patients choose between an injectable every two weeks or a daily pill.
鈥淒espite the availability of the injectable drugs, as safe and effective as they are, they’re vastly underutilized,鈥� he said. 鈥淢ore options available for patients will increase the odds that we get more people effectively treated.”
Heart disease remains the leading cause of death in the United States, with high levels of 鈥渂ad鈥� cholesterol among the biggest risk factors.
鈥淲hen your cholesterol is too high, your arteries suffer through developing buildups. And those buildups develop over decades to ultimately lead to things like strokes, heart attacks and premature death,鈥� Taylor said. 鈥淲e know from studies that this class of drugs reduces those risks.鈥�
Lipfendra is meant to be used alongside statin medications, diet and exercise. A pair of clinical trials showed it reduced low-density lipoprotein cholesterol, or “bad cholesterol,” , respectively.
The list price is $10.50 per day or $315 for a 30鈥慸ay supply. A Merck spokesperson said they expect out鈥憃f鈥憄ocket costs to be lower and it 鈥渨ill be available to patients in a matter of weeks.鈥�
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